Diagnosis of Predominant Negative Symptoms: Post-hoc Analyses of a Phase 3 Clinical Trial with Cariprazine Monotherapy and Risperidone

Abstract

Objective

To present, post hoc analyses from a controlled, prospective study of predominant negative symptoms (PNS) of schizophrenia on baseline patient characteristics, severity of symptoms and their variability among participating countries.

Methods

Data were analyzed from a phase 3, randomized, double-blind, active-controlled, parallel-group study in adult PNS patients with schizophrenia (EudraCT Number 2012-005485-36). Subjects with a PANSS factor score for negative symptoms (PANSS-FSNS) ≥ 24 and no pseudo-specific factors (e.g. high positive symptoms, extrapyramidal symptoms, depression) were randomized to cariprazine 4.5 mg/d (dose range: 3–6 mg/d) or risperidone 4 mg/d (dose range: 3–6 mg/d) for 26 weeks. Baseline values of PANSS-FSNS, individual PANSS items, personal and social performance (PSP), and clinical global impression of severity (CGI-S) were analyzed based on the data gained from 11 European participating countries.

Results

Average PANSS-FSNS of patients was 27.6 ± 2.48, reflecting severe negative symptoms. Patients were moderately ill (CGI-S 4.2 ± 0.75), with marked difficulties (PSP 48.4 ± 10.78) predominantly in social functioning. The investigated patient population was fairly homogeneous as shown by small variability in all three scores. Moreover, baseline values in the 11 countries presented low variability while number of enrolled patients per country showed high variance (n = 7–118). Narrative description of symptoms and individual PANSS items rated as most severe and prominent were in high correlation.

Conclusion

Post hoc evaluation of this predominant negative symptom study showed that, this patient population can be identified reliably by psychiatrist. Additional training on the judgment of personal and social relationships can increase the diagnostic accuracy.

Disclosure of interest

Employee of Gedeon Richter Plc.